The application applies to the use of Rituxan (rituximab) in previously-untreated patients with intermediate grade or aggressive non-Hodgkin’s lymphoma. The treatment would be used in combination with anthracycline-based chemotherapy regimens such as CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone).
Rituxan is already sold as a treatment for less severe forms non-Hodgkins lymphoma in relapsed or refractory patients. Non-Hodgkins lymphoma a cancer of the lymph system.
The FDA grants priority review status to products that are considered to be potentially significant therapeutic advancements over existing approved therapies in the treatment, diagnosis or prevention of a disease. Based on the designation of priority review, the FDA has up the middle of February 2006 to take action on the submission.
The filing was based on efficacy and safety data from three randomized, controlled, multicenter studies of Rituxan in combination with CHOP or other anthracycline-based chemotherapy induction regimens in 1,854 previously untreated patients with intermediate grade or aggressive, CD20-positive, B-cell, non-Hodgkin’s lymphoma. All three trials evaluated the efficacy endpoint of overall survival.